COVID-19 Serologic Strategies for Skilled Nursing Facilities

COVID-19 Clinical Trial

— CERO  

Official title:

COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270980
• Other study ID #: 20-01281
• Secondary ID: 3U54AG063546-02S
• Status: Completed
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: February 4, 2022

Study information

• Verified date: March 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The COVID-19 pandemic ravaged United States skilled-nursing facilities (SNFs). Novel strategies that maximize the safety and quality of life for SNF residents with ADRD and staff who care for them are urgently needed. Thus, the study's objectives are:

1. To rapidly plan and pilot test an intervention that leverages COVID-19 antibody and PCR status to pair SNF staff with residents in the safest way possible

2. To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Staff Stakeholders:

• Must be employees of ArchCare

• Must be members of included unit staff or those that float on those designated units

• Willing to participate in focus groups or semi-structured interviews with study team

Inclusion Criteria for Family Participants:

• Family members of residents who reside at either TCC or MMW (ArchCare facilities)

• Family member of resident who is on designated study unit or eligible to be transferred to such unit

• Willing to participate in focus groups or semi-structured interviews with study team

Inclusion Criteria for Resident Participants:

• Resident has ability to communicate and follow simple commands

• Resident has ability to communicate and follow simple commands

• English- or Spanish-speaking

• Resident has capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.

• Must agree to have serologic testing for COVID-19

• Agrees to remain on one of the facility units of study or to be transferred to such unit

Exclusion Criteria for Staff Stakeholders:

• Not employees of ArchCare

• Not members of included unit staff or those that float on those designated units

• Not willing to participate in focus groups or semi-structured interviews with study team

Exclusion Criteria for Family Participants:

• Not family members of residents who reside at either TCC or MMW (ArchCare facilities)

• Not family member of resident who is on designated study unit or eligible to be transferred to such unit

• Not willing to participate in focus groups or semi-structured interviews with study team

Exclusion Criteria for Resident Participants:

• Resident is not living in the unit of intervention

• Resident does not have ability to communicate and follow simple commands

• Not English- or Spanish-speaking

• Resident lacks capacity to consent assessed with standard questions used to assess capacity and does not have a surrogate who can provide consent.

• If resident lacks capacity, that resident does not assent with surrogate who provides assent

• Does not agree to have serologic testing for COVID-19

• Refuses to agree to remain on one of the facility units of study or to be transferred to such unit

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Cohorting
The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. Any resident who refuses serology testing will be treated as if they are serology negative as the safest strategy for risk of unwanted exposure.

Locations

Country	Name	City	State
United States	ArchCare at Mary Manning Walsh Home (MMW)	New York	New York
United States	ArchCare at Terence Cardinal Cooke Health Care Center (TCC)	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	Brown University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of New COVID-19 Detected Infections Among Residents		Up to Month 5
Secondary	Number of New COVID-19 Detected Infections Among Staff		Up to Month 5
Secondary	Number of Hospitalizations Over Time		Up to Month 5